Presently, there are no commercially available tests to determine favorable prognosis of a patient infected with human immunodeficiency virus (HIV) the causative agent of acquired immune deficiency syndrome (AIDS).
It would be of significant value to society to be able to use information to develop relatively favorable prognosis procedures with regard to a patient infected with HIV and at risk for development of acquired immune syndrome (AIDS).
Studies have been performed to evaluate cellular markers for their ability to predict the progression of HIV disease. For example, studies have shown that CD8 positive T cells (also referred to herein as CD8.sup.bright cells) in HIV positive subjects express an elevated level of HLA-DR antigen on the cell surface compared with the level in healthy control subjects. Further, the number of CD8 positive T cells that also express high levels of CD38 antigen increases continually throughout HIV disease progression, and is higher in AIDS patients compared with the level in asymptomatic HIV infected subjects (4-8,56,62,63).
These studies have all evaluated cellular markers for their ability to correlate certain cellular markers with bad prognosis (65,66,73). Before the present invention, there have been no cellular markers to determine favorable prognosis.
It is important to develop cellular markers to determine favorable prognosis with regard to HIV disease and AIDS. AIDS is a disease that is projected to develop yearly in approximately 5 percent of people infected with HIV. Clinical manifestations of AIDS include opportunistic infections such as pneumocystis pneumonia, severe cytomegalovirus infection, and toxoplasmosis or certain neoplasias such as Kaposi's sarcoma and lymphoma. During all stages of HIV disease, CD4 counts are used as a laboratory marker of the extent of the immunodeficiency disease. Low CD4 counts are a strong marker of poor prognosis in HIV-infected patients (43,57-60,65,66,73).
It is believed that most people with HIV infections will ultimately develop clinical AIDS. Furthermore, death from the complications of AIDS often occurs within months or years after clinical AIDS is diagnosed.
Most HIV infected persons remain healthy for many years despite infection with HIV. Likewise, some people with past clinical diagnosis continue to live productive lives for many years after first developing clinical AIDS.
There is a need for laboratory tests that identify those HIV infected patients who are more likely to have a favorable prognosis, slower disease progression, and stable disease compared with those patients who are likely to have poor prognosis, or more rapid disease progression.
There is currently a need to develop (1) methods to identify patients who need treatment along with the appropriate type of treatment, (2) apparatus, and (3) systems to determine the characteristics of favorable prognosis associated with HIV infection.